Effects of calcium infusion during exercise on bone health in older adults
PTH And Calcium Responses to Exercise in Older Adults Experiment 2 (PACE Sr. 2)
This study tests if giving calcium during exercise helps improve bone health in older adults who are taking medication for their bones.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT02580604 on ClinicalTrials.gov |
What this trial studies
This study investigates how maintaining serum calcium levels during exercise affects bone resorption markers in older adults. Participants aged 60-80 who are taking bisphosphonates will engage in two treadmill walking sessions, one with calcium infusion and the other with saline. Blood samples will be collected to measure levels of C-telopeptide, parathyroid hormone, total calcium, and serum ionized calcium, allowing researchers to assess the impact of calcium on bone activity during exercise.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 60-80 who are currently taking bisphosphonate medication.
Not a fit: Patients with severe bone density issues or those on medications affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing bone loss in older adults during physical activity.
How similar studies have performed: While there is ongoing research in this area, this specific approach using a calcium clamp during exercise is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adults aged 60-80 y * Currently taking a bisphosphonate medication Exclusion Criteria: * Use of medications (other than bisphosphonates) in the past 6 months known to affect bone metabolism (e.g., thiazide diuretics, oral glucocorticoids) * Bone Mineral Density (BMD) t score \< -3.0 at the total hip or lumbar spine * Known disease or condition associated with intestinal malabsorption * Moderate or severe renal impairment defined as an estimated glomerular filtration rate of \<60 mL/min/1.73m2 based on the Modified Diet in Renal Disease (MDRD) equation * Chronic hepatobiliary disease, defined as liver function tests (AST, ALT) \>1.5 times the upper limit of normal; if such values are obtained on initial screening and thought to be transient in nature, repeated testing will be allowed * Thyroid dysfunction, defined as an ultrasensitive TSH \<0.5 or \>5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement * Serum calcium \<8.5 or \>10.3 mg/dL Serum 25(OH)D \<20 ng/mL; volunteers with abnormal serum 25(OH)D values may be re-considered for participation in the study if serum 25(OH)D is \>20 ng/mL after vitamin D supplementation * Uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP\>90 mmHg; participants who do not meet these criteria at first screening will be re-evaluated, including after follow-up evaluation by the PCP with initiation or adjustment of anti-hypertensive medications * History of type 1 or type 2 diabetes * Cardiovascular disease; subjective or objective indicators of ischemic heart disease (e.g., angina, ST segment depression) or serious arrhythmias at rest or during the graded exercise test (GXT) without follow-up evaluation will be cause for exclusion; follow-up evaluation must include diagnostic testing (e.g., stress echocardiogram or thallium stress test) with interpretation by a cardiologist * Diagnosis or history of asthma
Where this trial is running
Aurora, Colorado
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Sarah J Wherry, PhD — University of Colorado, Denver
- Study coordinator: Sarah J Wherry, PhD
- Email: sarah.wherry@ucdenver.edu
- Phone: 303-724-1927
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.